EC approves CSL and Arcturus’ Kostaive

15 February 2025

The European Commission has granted marketing authorization for Kostaive (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older, from Australia’s CSL Limited (ASX: CSL) and US sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT), whose shares rose 10% to $18.05 on the news.

Kostaive is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). Kostaive is currently marketed in Japan against COVID-19 by Meiji Holdings (TYO: 2269).

CSL acquired a license for the vaccine from Arcturus in 2022 for an upfront $200 million payment, but the deal could provide the latter with as much as $4.5 billion if all goes according to plan.

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